The trial is taking place at:
O

Oncology Hematology Associates | Springfield, MO

Veeva-enabled site

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

H

Henlius Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Extensive Stage Small Cell Lung Cancer

Treatments

Drug: Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05468489
ASTRIDE (HLX10-005-SCLC301-E)

Details and patient eligibility

About

This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntary participation in clinical studies.

Male or female aged ≥ 18 years at the time of signing the ICF.

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).

No prior systemic therapy for ES-SCLC.

At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.

Major organs are functioning well.

Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.

An ECOG PS score of 0 or 1.

An expected survival ≥ 12 weeks.

Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.

Participant must keep contraception.

Exclusion criteria

Histologically or cytologically confirmed mixed SCLC.

Known history of severe allergy to any monoclonal antibody.

Known hypersensitivity to carboplatin or etoposide.

Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.

Pregnant or breastfeeding females.

Patients with a known history of psychotropic drug abuse or drug addiction.

Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Serplulimab + chemotherapy
Experimental group
Description:
Serplulimab + chemotherapy (carboplatin-etoposide)
Treatment:
Drug: Serplulimab + chemotherapy (carboplatin-etoposide)
Atezolizumab + chemotherapy
Active Comparator group
Description:
Atezolizumab + chemotherapy (carboplatin-etoposide)
Treatment:
Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Trial contacts and locations

84

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Central trial contact

Marshika Vickers

Data sourced from clinicaltrials.gov

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